Zeronil Combo 67 mg/60.3 mg Spot-on Solution for Small Dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fipronil; (S)-methoprene

Available from:

Chanelle Pharmaceuticals Manufacturing Limited

ATC code:

QP53AX65

INN (International Name):

Fipronil; (S)-methoprene

Dosage:

67, 60.3 mg/pipette

Pharmaceutical form:

Spot-on solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Dogs

Therapeutic area:

fipronil, combinations

Therapeutic indications:

Ectoparasiticide

Authorization status:

Authorised

Authorization date:

2018-04-20

Summary of Product characteristics

Health Products Regulatory Authority
06 November 2020
CRN009YGJ
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Zeronil Combo 67 mg/60.3 mg Spot-on Solution for Small Dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pipette of 0.67 ml contains:
ACTIVE SUBSTANCES:
Fipronil 67.00 mg
(S)-methoprene 60.30 mg
EXCIPIENTS:
Butylhydroxyanisole (E320) 0.13 mg
Butylhydroxytoluene (E321) 0.07 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Spot-on solution.
Clear amber solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
- To be used against infestations with fleas, alone or in association
with ticks and/or biting lice.
- Treatment of flea infestations (_Ctenocephalides _spp.).
Insecticidal efficacy against new infestations with adult fleas
persist for 8
weeks. Prevention of the multiplication of fleas by inhibiting the
development of eggs (ovicidal activity) and larvae and pupae
(larvicidal activity) originating from eggs laid by adult fleas for
eight weeks after application.
- Treatment of tick infestations (_Ixodes ricinus_, _Dermacentor
variabilis_, _Dermacentor reticulatus_, _Rhipicephalus sanguineus_).
The
product has a persistent acaricidal efficacy for up to 4 weeks against
ticks.
- Treatment of infestations with biting lice (_Trichodectes canis_).
The product can be used as part of a treatment strategy for the
control of Flea Allergy Dermatitis (FAD).
4.3 CONTRAINDICATIONS
In the absence of available data, the product should not be used on
puppies less than 8 weeks old and/or weighing less than 2
kg.
Do not use on sick (e.g. systemic diseases, fever) or convalescent
animals.
Do not use in rabbits, as adverse reactions with even mortality could
occur.
In absence of studies, the use of the product is not recommended in
non-target species.
This product is specifically developed for dogs. Do not use in cats
and ferrets, as this could lead to overdosing.
4.4 SPECIAL WARNINGS FOR EACH TARGE